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Biomedical Industry Updates

Biomedical news, views, insights and case studies from across the globe.

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That’s ODD: can your medicine benefit from incentives for treating rare disorders?

By Vergel Manalo | 31 July, 2020
The time, resources, and costs of developing and marketing medicines are extensive – putting treatments for rare disorders at a distinct disadvantage since the potential...
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TGA published review of safety and performance issues in Medical Device software

By Homi Dalal | 29 July, 2020
Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased...
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Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

By Homi Dalal | 22 July, 2020
The definitive risk management standard for medical devices - ISO 14971: 2019 - Medical Devices – Application of Risk Management and the accompanying guidance on...
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Video Gallery

Missed our live webinars? Watch now on demand.

Medical Device Software: Current Developments in the Regulatory World

Let’s talk clinical evidence reports – what you need to know

Faster Australian Medicine Approvals through Leveraging International Evaluations

Emergency approvals – moving things along in a Pandemic

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